Consumer medicine information

1. Why am I using YONDELIS?

YONDELIS contains the active ingredient trabectedin. YONDELIS is used for the treatment of patients with liposarcoma or leiomyosarcoma, which are types of soft tissue sarcoma, when previous medicines have been unsuccessful, or the patients are unsuited to receive them.
For more information, see Section 1. Why am I using YONDELIS? in the full CMI.

2. What should I know before I use YONDELIS?

Do not use if you have ever had an allergic reaction to trabectedin or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. Women of childbearing potential must use effective contraception during and for 3 months after YONDELIS treatment. Men of fertile age must use effective contraception during and for 5 months after YONDELIS treatment.
For more information, see Section 2. What should I know before I use YONDELIS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with YONDELIS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is YONDELIS given?

• The usual dose is 1.5 mg/m² of body surface area.

• YONDELIS will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 24 hours.

5. What should I know while using YONDELIS?

6. Are there any side effects?

The most common side effect is the increased levels of the yellow pigment bilirubin in the blood which might cause jaundice (a yellowing of the skin, mucous membranes and eyes). Serious side effects include fever, severe muscle pain or weakness, reaction at the site of injection, allergic reaction (when your body reacts to the medicine) and capillary leak syndrome (excessive accumulation of fluid in your tissues). For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Yondelis 1 mg powder for solution for infusion.

2 Qualitative and Quantitative Composition

For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for solution for infusion.
White to off-white powder.

4 Clinical Particulars

4.9 Overdose

There is limited data on the effects of trabectedin overdose. The major anticipated toxicities are gastrointestinal, bone marrow suppression and hepatic toxicity. There is no specific antidote for trabectedin currently available. In the event of an overdose, patients should be closely monitored and symptomatic supportive care measures instituted as required.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Trabectedin was genotoxic in both in vitro, Ames test and lymphoma assays and in vivo mouse micronucleus test.
Carcinogenicity. Long-term carcinogenicity studies have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. (1'R,6R,6aR,7R,13S,14S,16R)-5-(acetyloxy)-3',4',6,6a,7,13,14,16-octahydro-6',8,14-trihydroxy-7',9dimethoxy-4,10,23-trimethyl-spiro[6,16-(epithiopropanoxymethano)-7,13-imino-12H-1,3dioxolo[7,8]isoquino[3,2-b][3]benzazocine-20,1'(2'H)-isoquinolin]-19-one.
Molecular Formula: C₃₉H₄₃N₃O₁₁S.
Molecular Weight: MW: 761.84.
Chemical structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTRABEC.gif CAS number. 114899-77-3.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/YONDELST.gif